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18 days old

Principal Scientist - Biopharma

Kelly Services
Minneapolis, MN 55405
Kelly Scientific is actively seeking a **Principal Scientist** for a direct hire opportunity in **Oakdale, MN.** This role will play a key technical role in the Biopharmaceutical Services department that is responsible for overseeing or providing the transfer, development, and qualification/validation of analytical test methods and subsequent release and stability testing of biopharmaceuticals including, therapeutic proteins, synthetic peptides, oligonucleotides, and antibody-drug conjugates spanning Pre-Investigational New Drug through Phase III programs.


ESSENTIAL FUNCTIONS


+ Guarantees integrity in all aspects of the analytical support provided to our clients

+ Ensures team members in Biopharmaceutical Services consistently feel appreciated and valued

+ Continually builds positive, strong relationships with our customers

+ Defines, prioritizes, and honors all internal and external commitments

+ Ensures that high-quality data is safely generated in a cGMP regulated laboratory environment according to a defined plan and delivered on time within a signed scope of work

+ Proactively manages and/or executes the transfer, development, and qualification/validation of analytical test methods and subsequent release and stability testing of biopharmaceuticals

+ Serves as a subject matter expert and/or technical lead in multiple areas of biopharmaceutical testing for current and prospective clients

+ Routinely provides creative and flexible solutions in response to unexpected changes in demand within a fast-paced environment

+ Leads opportunities directed toward departmental stabilization, promoting collaborative teamwork, pursuing offering expansion, and realization of potential resources

+ Continuously drives strategic department improvement initiatives concerning people, equipment, practices, procedures, and policies via the utilization of lean six sigma tools

+ Provides team members with empowerment and training to support continual development


**QUALIFICATIONS**


Education requirements:


+ Bachelors degree in an applicable scientific discipline and 12 years of industry related experience or equivalent

+ Masters degree in an applicable scientific discipline and 10 years of industry related experience or equivalent

+ Ph.D. in an applicable scientific discipline and 6 years of industry related experience or equivalent


Required knowledge and skills:


+ A recognized subject matter expert in multiple techniques utilized in biopharmaceutical testing that may include HPLC/UPLC, CE-SDS, icIEF, SDS-PAGE, qPCR, ELISA, and LC-MS

+ A proven track record of successfully completing transfer, development, and phase appropriate qualification/validation of analytical test methods in a cGMP environment

+ Experience with testing a broad range of biopharmaceuticals that may include therapeutic proteins, synthetic peptides, oligonucleotides, and antibody-drug conjugates

+ Previous technical program management experience that includes the administration and oversite of associated practices, procedures, and polices

+ A proven history of effective communication (verbal, written, and visual) to technical and non-technical internal team members, cross-functional partners, and external clients

+ Experience with the broad range of regulatory guidance documents applicable to Pre-Investigational New Drug through Phase III programs for biotherapeutics

+ The ability to thrive with a high degree of acumen and resolve complex problems as a leader or individual contributor in a fast-paced, collaborative environment across site boundaries

+ Previous success guiding the acquisition and implementation of technical solutions and/or advancements requiring capital investment


Physical/Mental Requirements:


+ Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.


Working Environment:


+ Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors, and related items in a lab setting.

+ This role is working first shift Monday through Friday. From time to time this position may need to come in early, stay late, and occasional weekend work to meet the needs of clients.


Equal Opportunity Employer and will not discriminate against any applicant for employment based on race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.


\#TJP2022_SPEC


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-07-25 Expires: 2022-08-25

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Principal Scientist - Biopharma

Kelly Services
Minneapolis, MN 55405

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